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Conflicts of interest, News releases
chocolate milk, concussions, University of Maryland
The University of Maryland (UMD) today acknowledged serious problems with the process that produced flawed research and a misleading news release touting the benefits of a specific brand of chocolate milk for recovery from concussions in student athletes.
Concerns about the news release and underlying study were first identified by HealthNewsReview.org on January 5, 2016. Calling the release “out of bounds,” our review team cried foul over the university’s failure to produce any published study that could substantiate the release’s boastful claims.
“I did not become aware of this study at all until after it had become a news story,” Patrick O’Shea, UMD’s Vice President and Chief Research Officer, said in a teleconference. He says he took a look at both the chocolate milk and concussions news release and an earlier one comparing the milk to sports recovery drinks. “My reaction was, ‘This just doesn’t seem right. I’m not sure what’s going on here, but this just doesn’t seem right.’”
The university then convened a committee to review the news releases and the underlying research project. The committee’s report identifies problems in waiving required informed consent by students who were studied, in allowing product endorsements by faculty, in senior academic leaders abdicating their responsibility for ensuring scientific merit in research, in not reporting private gifts, and in recognizing potential conflicts of interests in partnering with private companies.
Acting on the advice of the committee, O’Shea said in a letter that the university would immediately take down the release from university websites, return some $200,000 in funds donated by dairy companies to the lab that conducted the study, and begin implementing some 15 recommendations that would bring the university’s procedures in line with accepted norms. The university’s conflict of interest policies were among the areas being prioritized for a “swift and comprehensive response,” O’Shea said.
HealthNewsReview.org is still reviewing the report, written by a panel of 5 research faculty, and the 60 supporting documents that UMD released today in advance of a news conference. More detailed analysis of the report is forthcoming.
Meanwhile, it’s initially clear that the committee has validated many of the concerns that HealthNewsReview.org voiced in our review of the UMD news release about this study. Among the major findings are these:
The lead researcher failed to disclose major conflicts of interest
At every juncture, Professor Shim, the lead study researcher, declared that he had no conflicts of interest to disclose related to this research. And according to the report, he maintained that position even when pressed directly by the dean of the School of Public Health at UMD. However, a detailed audit revealed that Dr. Shim’s lab was the beneficiary of large donations from Allied Milk Foundation, which is associated with First Quarter Fresh, the company whose chocolate milk was being studied and favorably discussed in the UMD news release. Allied Milk Foundation gave three gifts, totaling $200,000, to the University of Maryland College Park Foundation (UMCPF) that were specifically earmarked for Dr. Shim’s lab. Commenting on the arrangement, the committee said it found
…a concerning lack of understanding of the basic principles of conflict of interest (COI) in research at all levels of the process among those we interviewed (MIPS, administration, and faculty). The PI [principal investigator], as well as several others, expressed less concern for, and were perhaps less attentive to, the potential for a research COI in part because they felt that this project was in support of small business which is highly encouraged by the state and actively promoted by the university. When asked by the committee to explain why he had not declared a COI regarding the funding from the Allied Milk Foundation, Dr. Shim stated that since the money had not gone directly to him, but had been given to UMCPF to support his research, he did not consider the funding a COI.
UMD ignored warnings about the study’s shoddy design
Prior to implementation, the proposed research plan for the first phase of the study (comparing chocolate milk to sports recovery drinks) was sent out for independent review. While most reviewers gave the plan good marks, one reviewer raised red flags. According to the report:
…serious questions were raised by one reviewer who wrote that “the PI does not have any experience in nutritional/supplementation research”, the project is “missing numerous elements that would make this effective in concluding anything that would be useful to the company or to the state of the literature,” and the proposal is “missing major design elements that indicate the research staff understands how nutritional studies work in human subjects.”
Echoing the concerns of our reviewers, who questioned how the study design could possibly support the extravagant claims made in the news release, the review committee added:
There are simply too many uncontrolled variables to produce meaningful scientific results. We found this particularly troubling because students were used as subjects. We question if, under these circumstances, the project should have been funded at least until more in-depth reviews had been obtained. The Pl, however, appears to have considered this a research project that could be published in a peer-reviewed journal.
Not only were the problems in the first phase of research not addressed, but the plan for the second phase, which included looking at chocolate milk and concussion test scores in high school football players, was not sent out for independent review.
Nobody knew who was in charge of the news release
The University of Maryland says it will never again issue a news release on a study that has not been peer reviewed. The report found that while the release was widely circulated prior to distribution, nobody knew for sure who had the final say over what it could claim. “There is no institutional protocol for approval of press releases and lines of authority are poorly defined,” according to the report. It found that Dr. Shim was given default authority over the news release text, and that he disregarded generally accepted standards as to when study results should be disseminated in news releases. It recommended that in the future,
Press releases should never include study data or conclusions, even preliminary, until they have been subject to peer review and, under most circumstances, accepted for publication in an appropriate peer-reviewed journal or book. The strictest standards for peer review should be applied to research results that are based on human subjects or animals.
Attention to key safeguards needs more scrutiny
Key questions had been raised about the project since it involved the participation of high school athletes in a nearby school district, as well as members of the University’s women’s soccer team. Research involving children always requires additional safeguards and it was unclear whether these were in place during this study.
The report said that the University’s Institutional Review Board, or IRB, which is responsible for ensuring the safety of human subjects in research, waived the requirement that students sign informed consent notifications before participating, because it determined that there was minimal risk involved, and that the school district, not the university, would be working with students and would remove identifying information from concussion test results before providing them to researchers. The decision to exempt the project from routine consent requirements was made by the leaders of the IRB and not the entire board. The report calls for a review of this practice of granting “expedited approvals” in the future.
Stonewalling of news media not addressed
Although the report has much to say about the communications breakdowns that led to the distribution of the news release, it doesn’t address the university’s failure to engage with the news media when questions were initially raised about the study. As a public institution, the university is obligated to be transparent in its dealing with the news media. But it seems that if not for the size and scope of the public outcry, UMD might have been content to remain silent and let the story die. In the briefing following release of the report, Brian Ullmann, Associate Vice President of Marketing and Communications noted that reporters played their intended role as watchdogs, “The media attention from your outlet and others helped us get to the review process.” Although responsiveness to questions from the public was not addressed in the written report, Ullman said they heard the complaints from journalists loud and clear. “The committee has asked us to be much more transparent in how we handle media inquiries.”
Patrick O’Shea concluded the news briefing on the flawed studies and poor communication by saying, “It is important, but it is unusual. We believe this is not a normal occurrence, but I think it is important to catch these things early, so that everybody can learn from this, so that our colleagues will not do this again.” O’Shea said he has heard from colleagues at other universities who are learning lessons from what happened at the University of Maryland.
